NCT04474951

Brief Summary

The main purpose of this study is to evaluate the impact of food supplements (herbal remedies) on sign and symptoms induced by cancer therapies: Nettle will be administered for improvement of anemia and fatigue; Peppermint will be administered for improvement of nausea. Secondary aims of the trial are to evaluate the impact of these supplements on the quality of life and to evaluate their tolerability profile.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

July 14, 2020

Last Update Submit

July 16, 2020

Conditions

Breast CancerGynecologic Cancer

Keywords

breast cancerovarian cancerstinging nettlepeppermintanemiafatiguenausea

Outcome Measures

Primary Outcomes (3)

  • Anemia

    Assessment of hemoglobin levels every 4 weeks.

    Patients will be followed from date of enrollment for a maximum period of 6 months. Hemoglobin levels monitoring performed for a maximum period of 6 months or until the worsening of anemia (Hb<10 g/dL).

  • Fatigue

    Evaluation of fatigue with questionnaire "Brief Fatigue Inventory" - BFI, completed by the patients at day 1 of every cycle of chemotherapy.

    Patients will be followed from date of enrollment for a maximum period of 6 months.

  • Nausea

    Evaluation of nausea with questionnaire "Multinational Association of Supportive Care in Cancer" - MAT, completed by the patients at day 2 and day 5 of every cycle of chemotherapy.

    Patients will be followed from date of enrollment for a maximum period of 6 months.

Secondary Outcomes (2)

  • Quality of life level: questionnaire

    Patients will be followed from date of enrollment for a maximum period of 6 months.

  • Tolerability of food supplements

    Patients will be followed from date of enrollment for a maximum period of 6 months.

Study Arms (3)

Anemia

EXPERIMENTAL

Metastatic patients with grade 1 anemia and on treatment with anti-CDK 4/6 or PARP Inhibitors (10 patients) or on adjuvant therapy with hormonal therapy (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; hemoglobin levels will be assessed every 4 weeks for a maximum period of 6 months.

Dietary Supplement: Stinging Nettle

Fatigue

EXPERIMENTAL

Patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing fatigue not associated to anemia or with anemia grade 1 (10 patients) or associated to anemia grade 2 (10 patients) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Stinging Nettle Fluid Extract; the assessment of fatigue will be performed at every chemotherapy cycle, for a maximum period of 6 months.

Dietary Supplement: Stinging Nettle

Nausea

EXPERIMENTAL

20 patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane and showing nausea of any grade (without vomiting) will be enrolled. The control of the event will be evaluated during treatment with 40 drops TID of Peppermint Fluid Extract, associated to antiemetic therapy prescribed as per clinical practice; the assessment of nausea will be performed at every chemotherapy cycle, for a maximum period of 6 months.

Dietary Supplement: Peppermint

Interventions

Stinging NettleDIETARY_SUPPLEMENT

Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.

Anemia
PeppermintDIETARY_SUPPLEMENT

Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.

Nausea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female ≥ 18 years
  • Karnofsky Performance Scale (KPS) ≥ 90%
  • Breast or Gynecological cancer
  • Informed consent signed before every procedure study specific, on day 1 of therapy cycle

You may not qualify if:

  • Arm 1, 2 and 3: Previous intake of food supplements within 4 weeks from the enrollment
  • Arm 2: patients with evidence of anxiety or anxious-depressive syndrome; Clinical hypothyroidism not compensated by replacement therapy; Persistent insomnia
  • Arm 3: patients with evidence of anxiety or anxious-depressive syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii

Bologna, 40138, Italy

RECRUITING

Related Publications (3)

  • Tayarani-Najaran Z, Talasaz-Firoozi E, Nasiri R, Jalali N, Hassanzadeh M. Antiemetic activity of volatile oil from Mentha spicata and Mentha x piperita in chemotherapy-induced nausea and vomiting. Ecancermedicalscience. 2013;7:290. doi: 10.3332/ecancer.2013.290. Epub 2013 Jan 31.

    PMID: 23390455BACKGROUND

  • Rutto LK, Xu Y, Ramirez E, Brandt M. Mineral Properties and Dietary Value of Raw and Processed Stinging Nettle (Urtica dioica L.). Int J Food Sci. 2013;2013:857120. doi: 10.1155/2013/857120. Epub 2013 May 16.

    PMID: 26904610BACKGROUND

  • Meral I, Kanter M. Effects of Nigella sativa L. and Urtica dioica L. on selected mineral status and hematological values in CCl4-treated rats. Biol Trace Elem Res. 2003 Winter;96(1-3):263-70. doi: 10.1385/BTER:96:1-3:263.

    PMID: 14716106BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsAnemiaFatigueNausea

Interventions

stinging nettle lectinpeppermint oil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersHematologic DiseasesHemic and Lymphatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Claudio Zamagni, MD

    Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Zamagni, MD

CONTACT

051 2144548zamagniclaudio.sper@aosp.bo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Medical Oncologist

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

June 20, 2019

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)